Definium reports positive Phase 3 results for DT120 ODT in GAD, FDA breakthrough status in MDD

Definium Therapeutics said on November 9, 2026 that it reported positive topline results from the Phase 3 Voyage study in generalized anxiety disorder, which randomized 214 participants 1:1 to DT120 ODT 100 µg or placebo and met the primary endpoint and all key secondary efficacy endpoints with a high degree of statistical significance.¹ The study showed a statistically significant and clinically meaningful placebo-adjusted improvement of 5.4 points in Hamilton Anxiety Rating Scale total score from baseline at Week 12 (p<0.0001, Cohen's d=0.81).¹ No drug-related serious adverse events or suicidality signal were observed in Part A.¹

A second GAD study, Panorama, randomized 245 participants 2:1:2 to DT120 ODT 100 µg, a 50 µg control dose, or placebo, and also met its primary and key secondary endpoints with high statistical significance.¹ Panorama showed a placebo-adjusted HAM-A improvement of 5.1 points at Week 12 (p<0.0001, Cohen's d=0.64),¹ with no drug-related serious adverse events or suicidality signal in Part A.¹

In MDD, Definium received FDA Breakthrough Therapy designation following positive topline results from the Phase 3 Emerge study, which met its primary and key secondary endpoints.¹ The company is continuing enrollment in the Phase 3 Ascend study in MDD, expected to enroll about 165 participants in a 2:1:2 randomization, with topline data expected in 2027.¹ Definium said it is on track for a DT120 ODT NDA filing in the first half of 2027.¹ It also plans to start the Phase 3 Haven study in PTSD in 2027, enrolling about 200 participants 1:1 to DT120 ODT 100 µg or placebo, with CAPS-5 at Week 8 as the planned primary endpoint.¹

Separately, a Phase 2a trial of DT402 in five adults with autism spectrum disorder demonstrated positive initial results, with improvements observed in rigidity, social engagement, empathy, and reductions in anxiety and irritability following treatment¹, though the study endpoints were exploratory and not powered for statistical conclusions.¹ The company plans to evaluate multiple dosing paradigms in a new study expected to begin in 2027.¹

Financially, Definium reported cash, cash equivalents and investments of approximately $1.05 billion as of September 30, 2026, compared with $411.6 million as of December 31, 2025.¹ The company said it believes this will be sufficient to fund operations into 2030.¹